Clinical Research Associate (CRA) Location: Remote or New York, NY or Washington D.C Salary: TBD Type: Contract or Full-Time - Experienced Discipline: Research Required Education: 4 Year Degree
OVERVIEW: The CRA is responsible for monitoring and site management for multiple sites and multiple studies, and other clinical study administrative tasks of similar complexity, including developing informed consents, case report forms and the creation and maintenance of the electronic Trial Master File.
ESSENTIAL DUTIES AND RESPONSIBILITIES: • Prepare and conduct study initiation, monitoring and closeout visits at clinical investigative sites to ensure adherence to procedures, protocols and project plan in accordance with FDA /ICH (E6) regulations and guidance. • Assures that research site personnel are conducting the study according to the protocol and that sites are in compliance with all applicable regulatory requirements and GCP guidelines. • Interacts with the clinical study sites to resolve data queries, errors and omissions, and obtain additional information on potential serious adverse events. • Monitor clinical studies to ensure the quality, integrity and completeness of data verified against source documentation both on site and remotely. • Verifies the accuracy and completeness of CRF data against source documents; assures timely and complete data entry. • Serves as the primary liaison with research sites; monitors the day-to-day conduct of the study and resolves problems associated with the study; provides administrative and logistical support. • Prepares and submits accurate and timely monitoring reports. • Review, track and manage study documents for completeness and accuracy (clinical reports, Serious Adverse Events, review case report forms for accuracy and completeness as well as query resolution, study supplies, study device shipments, and enrollment logs). • Assume responsibility for multiple sites to ensure compliance with Good Clinical Practices (GCPs) and study procedures, including reviewing regulatory documents and preparing reports while meeting timelines/milestones. • Responsible for monitoring studies against defined milestones and timelines to assure that all deliverables are met as described in the Monitoring.
• Must be willing to assume monitoring and co-monitoring responsibilities as needed, involving travel across the United. • Interact with sites to discuss study specifics including IRB submissions, oversee study start-up activities, conduct training sessions for new site study staff. • Field phone calls and e-mails from sites and address issues in a timely manner. • Develop collaborative relationships with investigative sites. • Prime responsibility for maintenance of clinical trial master file TMF using electronic TMF program for all clinical sites. • Perform TMF reconciliation for all sites to determine status of TMF documents and address missing items. • Perform ongoing TMF reconciliation. • Maintain and update all trial spreadsheets. • Assists in improving and maintaining clinical SOPs. • Oversight for all study close-out activities and transfer of Clinical Trial Master Files into archives.
EDUCATION, EXPERIENCE, and TRAINING: • B.A./B.S. in life sciences or RN degree plus 1+ years' experience in clinical research trials monitoring. Knowledge of medical devices preferred. • Experience as both a field monitor and/or in-house CRA. • Experience with maintenance of clinical trial master file. o Demonstrated proficiency in GCPs and knowledge of other pertinent regulatory requirements. • Basic knowledge of medical terminology. • Ability to effectively work independently. o Excellent verbal and written communication skills and computer proficiency (Word, Excel, Outlook). • Well-organized and accustomed to maintaining excellent records. o Evidence of applied knowledge of applicable FDA regulations, guidance’s and consensus standards. • Able to manage multiple projects simultaneously. • Must be detail oriented with well-developed organizational and analytical skills. o Must enjoy working on fast-paced studies, both small and large trials with proven ability to be flexible and adaptable.
o Must have the interpersonal skills needed to communicate successfully with the Principle Investigators, Study Coordinators, Sponsor and Co-workers. • Experience with eCRFs. o 60% to 80% domestic travel required.
Since 2001, M Squared Associates has provided a full range of regulatory, quality and clinical consulting services to US and international medical technology firms. We specialize in devices and combination products that are reviewed by FDA's Center for Devices and Radiological Health (CDRH). Our corporate culture fosters innovative thinking; we thrive on the complicated and complex regulatory challenges commonly associated with ground-breaking technologies. We tailor our full service CRO capabilities to accommodate budget and timeline requirements for small feasibility studies, usability studies, clinical performance or marketing studies, and multicenter pivotal studies to support PMAs. We have experience conducting clinical trials with international companies, with clinical sites in the US, Canada, Brazil, Mexico and the EU.